Coronary AngiographyNCT01996553
The Prevalence of Radial Artery Occlusion in Diagnostic Cardiac Catheterization and Percutaneous Intervention
An observational study of Coronary Angiography and Radial Artery Occlusion, run by Jesse Brown VA Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to establish the rate of radial artery occlusion post transradial cardiac catheterization through different modalities. The study hypothesis is that specialized imaging can provide specific information to help identify hand complications after cardiac catheterization through the wrist. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Angiography, Radial Artery Occlusion
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Jul 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The subjects consist of patients who present to the cardiac catheterization laboratory for an angiogram or percutaneous intervention for the first time.
Who may be able to join
- Adult subjects over the age of 18 who present to the Jesse Brown VA cath lab for a diagnostic radial artery angiogram or percutaneous intervention will be considered for the study.
Who cannot join
- Any subject who is unable to give informed consent or declines to participate will be excluded.
- Patients who have previously had a cardiac catheterization through the radial artery will be excluded because it will not be known if the changes to the circulation of the hand is secondary to the current or previous transradial catheterization.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jesse Brown VA Medical Center
Chicago, Illinois, 60612
About this study
The purpose of this study is to establish the rate of radial artery occlusion post transradial cardiac catheterization through different modalities.
The study hypothesis is that specialized imaging can provide specific information to help identify hand complications after cardiac catheterization through the wrist.
Read the detailed description
The purpose of this study is to establish the rate of radial artery occlusion post diagnostic/interventional cardiac catheterization through different modalities, and to compare current assessment methods (such as Allen's test, Modified Barbeau test and duplex ultrasonography) to specialized imaging techniques for sensitivity and specificity of radial artery occlusion detection post transradial catheterization.
The study hypothesis is that specialized imaging can provide a specific focused analysis of hand characteristics to identify physiologic abnormalities as a result of radial artery occlusion post transradial catheterization.
- Conditions
- Coronary Angiography, Radial Artery Occlusion
- Keywords
- blood flow, regional, complications, disease, arterial obstructive, cardiac catheterization, radial artery
- Medical subject headings
- Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transradial cardiac catheterization | Patients undergoing cardiac catheterization through the radial artery. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic abnormalities of the hand
Blood flow to the hand in which transradial access was accomplished will be assessed for physiologic abnormalities as a result of radial artery occlusion post transradial catheterization
Measured: 1 day to 3 weeks post transradial cardiac catheterization
Physiologic abnormalities of the hand
Blood flow to the hand in which transradial access was accomplished will be assessed for physiologic abnormalities as a result of radial artery occlusion
Measured: 3 weeks to 3 months post transradial cardiac catheterization
Secondary outcomes (2)
Radial Artery Occlusion
Radial artery blood flow will be assessed for patency or occlusion 1 day to 3 weeks post transradial cardiac catheterization
Measured: 1 day to 3 weeks post transradial catheterization
Radial Artery Occlusion
Radial artery blood flow will be assessed for patency or occlusion 3 weeks to 3 months post transradial catheterization
Measured: 3 weeks to 3 months post transradial catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Coronary AngiographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jesse Brown VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Katherine Durham RN, BSN, CCRN, Jesse Brown VA Medical Center
- Investigators
- Katherine A Durham, MS, APN, Principal investigator, Jesse Brown VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01996553
- Sponsor's protocol ID
- 743024-6
- Status last verified
- Aug 2017
- First submitted
- 22 Nov 2013
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barbeau GR, Arsenault F, Dugas L, Simard S, Lariviere MM. Evaluation of the ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with the Allen's test in 1010 patients. Am Heart J. 2004 Mar;147(3):489-93. doi: 10.1016/j.ahj.2003.10.038.
PubMed 14999199Durham KA. Cardiac catheterization through the radial artery. Am J Nurs. 2012 Jan;112(1):49-56. doi: 10.1097/01.NAJ.0000410370.81555.54. No abstract available.
PubMed 22222403Dandekar VK, Vidovich MI, Shroff AR. Complications of transradial catheterization. Cardiovasc Revasc Med. 2012 Jan-Feb;13(1):39-50. doi: 10.1016/j.carrev.2011.08.005. Epub 2011 Nov 23.
PubMed 22115936Sanmartin M, Gomez M, Rumoroso JR, Sadaba M, Martinez M, Baz JA, Iniguez A. Interruption of blood flow during compression and radial artery occlusion after transradial catheterization. Catheter Cardiovasc Interv. 2007 Aug 1;70(2):185-9. doi: 10.1002/ccd.21058.
PubMed 17203470Bazemore E, Mann JT 3rd. Problems and complications of the transradial approach for coronary interventions: a review. J Invasive Cardiol. 2005 Mar;17(3):156-9. No abstract available.
PubMed 15867445
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prevalence of Radial Artery Occlusion in Diagnostic Cardiac Catheterization and Percutaneous Intervention
- ClinicalTrials.gov ID
- NCT01996553
- Acronym / sponsor ID
- 743024-6
- Conditions
- Coronary Angiography, Radial Artery Occlusion
- Keywords
- blood flow, regional, complications, disease, arterial obstructive, cardiac catheterization, radial artery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Jesse Brown VA Medical CenterUS federal agency
- Study start
- Apr 2013
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 27 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to establish the rate of radial artery occlusion post transradial cardiac catheterization through different modalities.
The study hypothesis is that specialized imaging can provide specific information to help identify hand complications after cardiac catheterization through the wrist.
Detailed description
The purpose of this study is to establish the rate of radial artery occlusion post diagnostic/interventional cardiac catheterization through different modalities, and to compare current assessment methods (such as Allen's test, Modified Barbeau test and duplex ultrasonography) to specialized imaging techniques for sensitivity and specificity of radial artery occlusion detection post transradial catheterization.
The study hypothesis is that specialized imaging can provide a specific focused analysis of hand characteristics to identify physiologic abnormalities as a result of radial artery occlusion post transradial catheterization.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transradial cardiac catheterization | – | –Patients undergoing cardiac catheterization through the radial artery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The subjects consist of patients who present to the cardiac catheterization laboratory for an angiogram or percutaneous intervention for the first time.
Key inclusion criteria (1 listed)
- Adult subjects over the age of 18 who present to the Jesse Brown VA cath lab for a diagnostic radial artery angiogram or percutaneous intervention will be considered for the study.
Key exclusion criteria (2 listed)
- Any subject who is unable to give informed consent or declines to participate will be excluded.
- Patients who have previously had a cardiac catheterization through the radial artery will be excluded because it will not be known if the changes to the circulation of the hand is secondary to the current or previous transradial catheterization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Physiologic abnormalities of the hand
Time frame: 1 day to 3 weeks post transradial cardiac catheterization
Blood flow to the hand in which transradial access was accomplished will be assessed for physiologic abnormalities as a result of radial artery occlusion post transradial catheterization
Physiologic abnormalities of the hand
Time frame: 3 weeks to 3 months post transradial cardiac catheterization
Blood flow to the hand in which transradial access was accomplished will be assessed for physiologic abnormalities as a result of radial artery occlusion
2 secondary outcomes
Radial Artery Occlusion
Time frame: 1 day to 3 weeks post transradial catheterization
Radial Artery Occlusion
Time frame: 3 weeks to 3 months post transradial catheterization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2017.
- Background: PubMed 14999199Barbeau GR, Arsenault F, Dugas L, Simard S, Lariviere MM. Evaluation of the ulnopalmar arterial arches with pulse oximetry and plethysmography: comparison with the Allen's test in 1010 patients. Am Heart J. 2004 Mar;147(3):489-93. doi: 10.1016/j.ahj.2003.10.038.
- Background: PubMed 22222403Durham KA. Cardiac catheterization through the radial artery. Am J Nurs. 2012 Jan;112(1):49-56. doi: 10.1097/01.NAJ.0000410370.81555.54. No abstract available.
- Background: PubMed 22115936Dandekar VK, Vidovich MI, Shroff AR. Complications of transradial catheterization. Cardiovasc Revasc Med. 2012 Jan-Feb;13(1):39-50. doi: 10.1016/j.carrev.2011.08.005. Epub 2011 Nov 23.
- Background: PubMed 17203470Sanmartin M, Gomez M, Rumoroso JR, Sadaba M, Martinez M, Baz JA, Iniguez A. Interruption of blood flow during compression and radial artery occlusion after transradial catheterization. Catheter Cardiovasc Interv. 2007 Aug 1;70(2):185-9. doi: 10.1002/ccd.21058.
- Background: PubMed 15867445Bazemore E, Mann JT 3rd. Problems and complications of the transradial approach for coronary interventions: a review. J Invasive Cardiol. 2005 Mar;17(3):156-9. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine A Durham, MS, APN principal investigator
Jesse Brown VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Angiography and Radial Artery Occlusion, run by Jesse Brown VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physiologic abnormalities of the hand (time frame: 1 day to 3 weeks post transradial cardiac catheterization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01996553, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2017.